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News Release

 
   PO 360
   Trenton, NJ 08625-0360

   For Release:
   March 28, 2002

 

Clifton R. Lacy, M.D.
Acting Commissioner

For Further Information Contact:
Dennis McGowan or Marilyn Riley
609-984-7160


Background Information on the CDC's Project RESPECT
   

TRENTON -Approximately 900 Newark residents who participated in a federal Centers for Disease Control and Prevention (CDC) research study in the 1990's were mailed letters by the CDC this week informing them that test results for herpes simplex virus (HSV) are now available. More than 400 study participants tested positive for the virus.

The individuals being contacted were participants in a five-city, five-state study called Project RESPECT, conducted between 1993 and 1996, to examine the effectiveness of prevention approaches among sexually transmitted disease (STD) clinic participants.

Study participants were tested for numerous STDs and given their results throughout the study period. Early in the study, however, the reliability of the herpes test available at the time was questioned, according to the CDC. Three cities decided to amend their participant consent forms and dropped HSV notification. Project managers in Newark and Denver did not change their consent forms after deciding that study participants in their jurisdictions would be told their HSV test results even though reliable results would not be available for six months or more. When the Newark project manager informed the New Jersey Department of Health and Senior Services (DHSS) in the fall of 1996 that the study had ended, the CDC had not yet completed the HSV tests.

In October 1997, the CDC completed its tests for HSV on all specimens received from the five cities but failed to realize at the time that the consent forms used in two of those cities - Newark and Denver - required that participants be notified of their results. The CDC first informed the DHSS of this issue in June 2001. As a result, the DHSS and the CDC jointly developed a plan for notifying former study participants.

CDC personnel were assigned to New Jersey to create a database from Project RESPECT records. That database was completed in December 2001. The agencies developed a notification letter, protocol and counseling guidelines, and the department assigned a trained individual to inform and counsel former study participants regarding their test results.

The CDC's Institutional Review Board recently approved the notification protocol that will be followed by staff of the DHSS STD program and staff in the Newark Department of Health and Human Services. Former participants who respond to the outreach will be given their test results; provided information on HSV; offered an exam and viral culture for those with symptoms; offered a new, more specific herpes test upon request; and offered testing for their sexual partners.

The DHSS has notified the U.S. Department of Health and Human Services' Office for Human Research Protection (OHRP) of its concerns related to the research conducted by the CDC. The CDC is making a similar referral to the OHRP.

In addition to the CDC notification letter, the DHSS will send follow-up letters next week to further inform study patients that their test results are available through the Newark Department of Health and Human Services and to provide them additional contact options for more information.

"We will make a concerted effort to reach every study participant to provide them with accurate information and appropriate counseling and evaluation," said Clifton R. Lacy, M.D., Acting Commissioner of the New Jersey Health and Senior Services.

Project RESPECT study participants with questions or concerns should contact the Newark Department of Health and Human Services' STD Program at 973-648-2572 or 2227, the CDC at 800-584-8814, or the DHSS at 609-588-7526.

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Department of Health and Senior Services
P. O. Box 360
Trenton, NJ 08625-0360

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